The fast track status for the investigational, oral factor XIa (FXIa) inhibitor (antithrombotic) has been granted in ischemic stroke, acute coronary syndrome and atrial fibrillation


Milvexian is an investigational, oral factor XIa inhibitor. (Credit: Bristol-Myers Squibb Company)

Bristol Myers Squibb (BMS) and Janssen Pharmaceuticals announced that their jointly developed milvexian has received fast track designation from the US Food and Drug Administration (FDA) for all its three prospective indications.

The fast track status has been granted in ischemic stroke, acute coronary syndrome (ACS), and atrial fibrillation (AF).

Milvexian is an investigational, oral factor XIa (FXIa) inhibitor (antithrombotic). It is currently being assessed for the prevention and treatment of major thrombotic conditions in the phase 3 Librexia programme.

The late-stage clinical study is evaluating the investigational drug for the three indications for which it has secured the FDA fast track designation.

Librexia is expected to generate data from around 50,000 patients.

Bristol Myers Squibb vice president and Milvexian global programme lead Puneet Mohan said: “This Fast Track Designation underscores the unmet need that exists in the treatment of thromboembolic conditions.

“The goal of milvexian and the Librexia program is to enhance the benefit-risk profile in the treatment of these conditions by delivering reduced thrombotic events and less bleeding in at-risk patients than the current standard of care.”

Based on positive phase 2 efficacy and safety data, the Librexia programme intends to assess the potential of milvexian in increasing the benefit-risk profile related to treating patients with the three conditions.

The phase 3 programme aims to advance beyond the standard of care and help enhance the results in a wide variety of patients with thrombotic diseases.

Janssen research and development global therapeutic area head James List said: “For milvexian to receive Fast Track Designation from the FDA for all three indications demonstrates the enormous unmet need that still exists for the treatment of thrombotic events, like heart attack and stroke.

“We are now focused on enrolling patients to these trials with urgency, bringing us one step closer to potentially improving outcomes in a wide range of patients with thrombotic diseases.”

The Librexia programme was launched in March 2023 by Bristol Myers Squibb and the Janssen Pharmaceutical Companies of Johnson & Johnson.